Rectal CancerNCT04761536
Volume-outcome Relationship in Rectal Cancer Surgery
An observational study of Rectal Cancer and Anastomotic Leak Rectum, run by University of Rome Tor Vergata.
Trial summary
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Anastomotic Leak Rectum
- What is being tested?
- Rectal cancer case centralization
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involved all consecutive eligible patients undergoing elective restorative anterior rectal resection (ARR) for rectal cancer between November 2016 and December 2020 in our Minimally Invasive Surgery Unit of Tor Vergata University Hospital unit (Group A). Outcomes for Group A were compared with an historical control group, consisting of all consecutive patients undergoing ARR in the same hospital between January 2006 and October 2016 (Group B).
Who may be able to join
- diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al.,
- elective setting
- anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).
Who cannot join
- age below age of 18,
- inflammatory bowel disease,
- acquired or congenital immunodeficiency,
- preoperative infection,
- pregnancy,
- ASA IV,
Show all 10Show fewer
- presence of synchronous cancers,
- abdominoperineal resection (APR),
- failure to perform rectal resection and primary anastomosis,
- emergency setting.
About this study
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).
- Conditions
- Rectal Cancer, Anastomotic Leak Rectum
- Being tested
- Rectal cancer case centralization
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal cancer case centralizationOther
In November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice.
| Study group | Role | What they receive |
|---|---|---|
| A | patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases Receives: Other: Rectal cancer case centralization | |
| B | patients undergoing ARR with primary anastomosis between January 2006 and October 2016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated
Measured: up to 30 days after discharge
Secondary outcomes (14)
Postoperative complications
rate of any surgical site infection clinically demonstrated
Measured: up to 30 days after discharge
Surgical site infection
Rate of any complication after rectal resection
Measured: up to 30 days after discharge
Pneumonia
rate of radiologically demonstrated pneumonia
Measured: up to 30 days after discharge
Ileus
rate of any ileus clinically demonstrated
Measured: up to 30 days after discharge
Bleeding
Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection
Measured: up to 30 days after discharge
Reoperation
Rate of any reoperation
Measured: up to 30 days after discharge
Readmission
Rate of any unplanned readmission after discharge
Measured: up to 90 days after discharge
30-days-mortality
Rate of any mortality
Measured: up to 30 days after discharge
1-year stoma persistence
rate of stoma persistence
Measured: up to one year after surgery
Length of hospital stay
number of days between primary rectal resection and discharge
Measured: up to 30 days after discharge
Use of minimally invasive approach
rate of minimally invasive rectal ARR performed
Measured: up to 30 days after discharge
Operative time
Mean operative time
Measured: up to 30 days after discharge
Conversion to open surgery
rate of conversion form laparoscopy to one surgery
Measured: up to 30 days after discharge
need of postoperative blood transfusion
rate of postoperative transfusion
Measured: up to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startJan 2006
- Primary completionDec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761536
- Sponsor's protocol ID
- REGISTROSPERIMENTAZIONI XX/21
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume-outcome Relationship in Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04761536
- Acronym / sponsor ID
- REGISTROSPERIMENTAZIONI XX/21
- Conditions
- Rectal Cancer, Anastomotic Leak Rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Rectal cancer case centralizationpatients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases |
| B | – | –patients undergoing ARR with primary anastomosis between January 2006 and October 2016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involved all consecutive eligible patients undergoing elective restorative anterior rectal resection (ARR) for rectal cancer between November 2016 and December 2020 in our Minimally Invasive Surgery Unit of Tor Vergata University Hospital unit (Group A). Outcomes for Group A were compared with an historical control group, consisting of all consecutive patients undergoing ARR in the same hospital between January 2006 and October 2016 (Group B).
Key inclusion criteria (3 listed)
- diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al.,
- elective setting
- anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).
Key exclusion criteria (10 listed)
- age below age of 18,
- inflammatory bowel disease,
- acquired or congenital immunodeficiency,
- preoperative infection,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal cancer case centralizationIn November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice. | Other | A |
Primary outcome
Anastomotic leak
Time frame: up to 30 days after discharge
rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated
14 secondary outcomes
Postoperative complications
Time frame: up to 30 days after discharge
Surgical site infection
Time frame: up to 30 days after discharge
Pneumonia
Time frame: up to 30 days after discharge
Ileus
Time frame: up to 30 days after discharge
Bleeding
Time frame: up to 30 days after discharge
Reoperation
Time frame: up to 30 days after discharge
Readmission
Time frame: up to 90 days after discharge
30-days-mortality
Time frame: up to 30 days after discharge
1-year stoma persistence
Time frame: up to one year after surgery
Length of hospital stay
Time frame: up to 30 days after discharge
Use of minimally invasive approach
Time frame: up to 30 days after discharge
Operative time
Time frame: up to 30 days after discharge
Conversion to open surgery
Time frame: up to 30 days after discharge
need of postoperative blood transfusion
Time frame: up to 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Anastomotic Leak Rectum, run by University of Rome Tor Vergata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak (time frame: up to 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.